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Abstract Details
Sofosbuvir-Velpatasvir-Voxilaprevir in Adolescents 12 to 17 Years Old With Hepatitis C Virus Infection
Hepatology. 2022 Feb 3. doi: 10.1002/hep.32393. Online ahead of print.
Meyer Children's University Hospital and Department NEUROFARBA, University of Florence, Florence, Italy.
Birmingham Women's and Children's Hospital and University of Birmingham, Birmingham, UK.
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
University of Naples Federico II, Naples, Italy.
Karol Marcinkowski University of Medical Sciences, Poznan, Poland.
Luigi Sacco Hospital, University of Milan, Milan, Italy.
Medical University Wroclaw, Wroclaw, Poland.
Gilead Sciences, Inc., Foster City, California, USA.
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Collegium Medicum in Bydgoszcz Nicolaus Copernicus University in Torun, Poland.
King's College Hospital, London, UK.
Abstract
Background & aims: Sofosbuvir-velpatasvir-voxilaprevir is a pangenotypic regimen for chronic hepatitis C virus (HCV) infection. In the United States and Europe, sofosbuvir-velpatasvir-voxilaprevir once daily for 12 weeks is indicated for adults previously receiving an HCV NS5A inhibitor. In Europe, sofosbuvir-velpatasvir-voxilaprevir is also indicated in the absence of prior HCV direct-acting antiviral (DAA) therapy as an 8- or 12-week regimen. In an open-label study, we evaluated the safety, efficacy, and pharmacokinetics of sofosbuvir-velpatasvir-voxilaprevir in adolescents 12 to 17 years with chronic HCV of any genotype.
Methods: In this Phase 2, multi-center study, sofosbuvir-velpatasvir-voxilaprevir 400/100/100 mg daily was administered to adolescents for 8 weeks if DAA-naïve or for 12 weeks for cirrhosis or prior DAA failure. The key efficacy endpoint was sustained virologic response 12 weeks after therapy (SVR12). Intensive pharmacokinetic sampling was done in 14 patients at week 2 or 4, and samples for population pharmacokinetics were collected in all patients.
Results: All patients (n=21) were naïve to HCV DAAs, and none had cirrhosis. HCV genotype 3a infection was most common, occurring in 43% of patients. Overall, 100% of patients (21/21) reached SVR12. The most common adverse events were abdominal pain and headache (24% each) and nausea (19%); no adverse events led to discontinuation. The only serious adverse event, hypotension, was considered related to study drug and resolved the same day without interruption of treatment. Sofosbuvir-velpatasvir-voxilaprevir exposures were similar to those observed in adults.
Conclusion: The pangenotypic regimen of sofosbuvir-velpatasvir-voxilaprevir is highly efficacious and well-tolerated in treating chronic HCV infection in adolescents.